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A Study of SU11248 In Patients With Metastatic Breast Cancer Who Have Failed Selected Other Therapies.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00078000
Recruitment Status : Completed
First Posted : February 18, 2004
Last Update Posted : November 26, 2008
Information provided by:

Study Description
Brief Summary:
Assessment of safety and efficacy of SU11248 in patients with metastatic breast cancer who have failed selected other therapies.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Drug: SU011248 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study Of The Efficacy And Safety Of SU011248 In Patients With Metastatic Breast Cancer
Study Start Date : March 2004
Study Completion Date : November 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Anti-tumor efficacy

Secondary Outcome Measures :
  1. Tumor control survival safety pharmacokinetics

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Anthracycline and taxane-refractory or intolerant metastatic breast cancer
  • Female

Exclusion Criteria:

  • Prior treatment with 3 or greater regimens of chemotherapy in the advanced/metastatic disease setting beyond those containing anthracyclines/taxanes.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00078000

United States, California
Pfizer Investigational Site
Greenbrae, California, United States, 94904
Pfizer Investigational Site
Los Angeles, California, United States, 90095
Pfizer Investigational Site
San Francisco, California, United States, 94115
United States, Colorado
Pfizer Investigational Site
Aurora, Colorado, United States, 80010
United States, Illinois
Pfizer Investigational Site
Chicago, Illinois, United States, 60612-3824
United States, Indiana
Pfizer Investigational Site
Indianapolis, Indiana, United States, 46202
United States, Maryland
Pfizer Investigational Site
Baltimore, Maryland, United States, 21231
United States, Massachusetts
Pfizer Investigational Site
Boston, Massachusetts, United States, 02114
Pfizer Investigational Site
Boston, Massachusetts, United States, 02115
Pfizer Investigational Site
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Study Director: Pfizer CT.gov Call Center Pfizer
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00078000     History of Changes
Obsolete Identifiers: NCT00095615
Other Study ID Numbers: A6181002
First Posted: February 18, 2004    Key Record Dates
Last Update Posted: November 26, 2008
Last Verified: November 2008

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors